The Software Engineer with a focus on Cybersecurity will play a critical part in ensuring that software integrated into our diagnostic platforms meets cybersecurity, regulatory, and quality requirements. This system-level engineering role will facilitate software development, cybersecurity testers, and regulatory functions, ensuring secure design and compliant documentation throughout the product lifecycle.

• Integrate cybersecurity requirements into the design and development of software for diagnostic platforms (coding on embedded software)
• Ensure compliance with FDA cybersecurity guidance (pre-market and post-market) and applicable North American regulations
• Collaborate with software development teams to ensure secure-by-design implementation
• Translate cybersecurity and regulatory requirements into clear technical specifications and documentation
• Contribute to and maintain Design History File (DHF) documentation in compliance with design control requirements
• Support software lifecycle activities aligned with IEC 62304
• Participate in risk management activities in accordance with ISO 14971 (e.g., threat modeling, risk analysis, mitigation strategies)
• Review system architecture and design to ensure alignment with secure development principles
• Act as a cross-functional liaison between R&D, Quality, Regulatory, and Software Engineering teams
• Other duties as assigned
• Travel 10-15% international travel

• Bachelors or Masters degree in Software Engineering, Computer Engineering, or related field
• 5 years of experience in software engineering or system-level roles
• Recent experience in cybersecurity, preferably within the medical device or other regulated industry
• Strong understanding of:
  • FDA cybersecurity guidance (pre-market and post-market)
  • IEC 62304 software lifecycle processes
  • ISO 14971 risk management principles
• Experience working with regulated design documentation (e.g., DHF, technical files)
• Ability to interpret and communicate complex technical and regulatory requirements across multidisciplinary teams
• Experience with Software and Hardware integration
• Strong collaboration and stakeholder communication skills
• Experience with threat modeling, vulnerability assessment, or security risk management
• Preferred:
• Experience as a Software Lead or Technical Lead capacity
• Familiarity with Laboratory Information Systems (LIS) and remote device management (IoT)
• Knowledge of additional standards and best practices, such as:
• AAMI TIR57 / TIR97 (Medical device Cybersecurity)
• IEC 81001-5-1 (secure product development lifecycle)
• Exposure to secure development frameworks (e.g., NIST Cybersecurity Framework, OWASP)
• Basic knowledge of French or Korean language